Principal Software Quality Leader – Medical Devices Equity

Metric Bio; California; On-site; USD 150,000 - 230,000; Full time

Job summary

Metric Bio is seeking a Principal Software Quality Engineer to provide technical ownership of software quality and regulatory compliance for next-generation minimally invasive medical devices.

This newly created role guides design controls, verification and validation, risk management and software lifecycle processes, while driving cybersecurity readiness and regulatory submissions. You will partner with R&D, Regulatory and Quality teams and mentor engineers across the organization.

Qualifications

• 10+ years in Software Quality Engineering, testing or development in regulated medical devices.
• Expertise in IEC 62304, FDA software requirements, and medical device cybersecurity.
• Experience with Class II/III medical devices, energy-based or cardiovascular tech.
• Knowledge of software V&V, design controls, ISO 14971, CAPA and regulatory documentation.
• Independent, collaborative technical expert guiding software teams and influencing cross-functional decisions.

Responsibilities

• Serve as the technical authority for software quality, guiding teams on FDA requirements, IEC 62304 and regulatory compliance.
• Lead software quality oversight across design controls, verification & validation, risk management and software lifecycle processes.
• Drive software cybersecurity compliance, supporting regulatory submissions, risk assessments and evolving FDA requirements.
• Partner with R&D, Regulatory and Quality teams, mentoring engineers and strengthening internal software quality capabilities.

Skills

Software quality

Regulatory compliance

IEC 62304

FDA requirements

Software V&V

Design controls

Cybersecurity

Leadership

Cross-functional

Job description

Metric Bio is seeking a Principal Software Quality Engineer to provide technical ownership of software quality and regulatory compliance for next-generation minimally invasive medical devices.

This newly created role guides design controls, verification and validation, risk management and software lifecycle processes, while driving cybersecurity readiness and regulatory submissions. You will partner with R&D, Regulatory and Quality teams and mentor engineers across the organization.